Molecular Prognosis of Lymphomas of the Central Nervous System (ALYCE-molecular)

Central Nervous System Lymphoma Clinical Trial

— ALYCEmolecular  

Official title:

Molecular Prognosis of Lymphomas of the Central Nervous System (ALYCE-molecular)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03859544
• Other study ID #: 69HCL17_0692
• Status: Recruiting
• Start date: January 1, 2016
• Est. completion date: January 1, 2020

Study information

• Verified date: February 2019
• Source: Hospices Civils de Lyon
• Contact: Hervé GHESQUIERES, Pr
• Email: herve.ghesquieres[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Central nervous system lymphoma (PCNSL) is a diffuse large B cell lymphoma (DLBCL) entity with a particularly poor prognosis (median survival less than 3 years). They are still poorly characterized biologically, largely because of their rarity (300 cases / year in France) and the difficulty for obtaining a material of sufficient quality and quantity. It is nevertheless assumed that their pathophysiology is particular, since they develop exclusively in an immunological sanctuary, and that they present some characteristic molecular abnormalities (mutation of MYD88 or TBL1XR1 for example).

A collection of 74 PCNSLs has created, clinically annotated, from which frozen material is available in addition to the material fixed and included in paraffin (cohort ALYCE). Informed consent was gathered for all patients. Comparative Genomic Hybridization-array analysis of this cohort has already revealed abnormalities associated with a poor prognosis (unpublished data). The objective of this study is to complete this analysis by sequencing a panel of 96 mutant genes recurrently in DLBCLs and PCNSLs, and the molecular determination of the original cell by the (RT-MLPA) Reverse Transcriptase-Multiplex Ligation-dependent Probe Amplification technique.

The integration of genetic, molecular and transcriptomic data may define prognostic markers and open perspectives for translational research in PCNSL.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults

• With a lymphoma of the central nervous system

• Patients having signed the consent for the conservation of their samples within the cohort

Exclusion Criteria:

• <18 old years

• Other diagnosis than lymphoma of the central nervous system

• No consent form signed

Related Conditions & MeSH terms

• Central Nervous System Lymphoma
• Lymphoma

Intervention

Other:
• Retrospective study
Retrospective study to search mutations associated with Central nervous system lymphoma and study of the prognostic impact (overall survival and progression-free survival) of these mutations.

Locations

Country	Name	City	State
France	Service d'hématologie biologique - Centre Hospitalier Lyon Sud - HCL	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	Analysis of progression-free survival correlated with genomic data and mutation data	Up to 48 months